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AstraZenecaAnnouncement

06/09/2014 02:10

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RNS Number : 3129J
AstraZeneca PLC
11 June 2014 
 
ASTRAZENECA TO PRESENT NEW DATA FROM ITS BROAD PORTFOLIO IN WIDE RANGE OF
PATIENT POPULATIONS AT THE AMERICAN DIABETES ASSOCIATION 74TH SCIENTIFIC
SESSIONS® 
 
43 abstracts on approved products and an investigational compound accepted for
presentation 
 
First data from Phase III trial of saxagliptin/dapagliflozin combination
presented as a late-breaker 
 
First six-year, open-extension to the DURATION-1 trial examining the efficacy
and tolerability of exenatide will be presented 
 
AstraZeneca today announced that 43 abstracts reporting results of the
company's research and development in diabetes have been accepted for
presentation at the 74th Scientific Sessions® of the American Diabetes
Association (ADA) in San Francisco, 13-17 June 2014. Clinical data from
studies evaluating multiple approved products, including Forxiga®
(dapagliflozin, marketed in the US as Farxiga™), Bydureon® (exenatide
extended-release for injectable suspension) and Onglyza® (saxagliptin), as
well as the investigational combination of saxagliptin and dapagliflozin,
demonstrate AstraZeneca's continued commitment to addressing unmet medical
needs across a wide spectrum of type 2 diabetes patients in different stages
of the disease. 
 
Pascal Soriot, Chief Executive Officer, AstraZeneca, said: "The robust
scientific data that will be presented at ADA further strengthen our broad
innovative portfolio that spans the entire spectrum of non-insulin
anti-diabetic treatments. Our continued focus on advancing scientific
knowledge reinforces our long-term commitment to diabetes, a core strategic
area for us and an important platform for returning AstraZeneca to growth." 
 
"Diabetes is a progressive and complex disease which demands combination
approaches to further improve patient care," said Briggs Morrison, MD,
Executive Vice President, Global Medicines Development & Chief Medical
Officer, AstraZeneca. "Our data accepted for presentation at this year's ADA,
including trials evaluating our medicines in patients with significant
comorbidities and in combination with other anti-diabetic agents, reflect
AstraZeneca's efforts to provide these treatment options that address the
needs of patients at different stages of the disease." 
 
Notable data on an AstraZeneca investigational compound at ADA include: 
 
·     A late-breaker of the first presentation of Phase III data evaluating
the investigational combination of saxagliptin/dapagliflozin as a dual add-on
therapy in adult patients with type 2 diabetes who were inadequately
controlled on metformin,  the top-line results of which were announced in May.
Results being presented at ADA, and published in the abstract available in
Diabetes, include secondary outcome measures on body weight and efficacy.
(#127-LB, Sunday, 15 June, 12:00 PM PDT) i  
 
Notable data on approved AstraZeneca products at ADA include: 
 
·     An analysis from nine double-blind, placebo-controlled trials evaluating
the safety of dapagliflozin in elderly patients (#269-OR, Monday, 16 June,
9:30 AM PDT) ii  
 
·     An analysis from three randomised controlled trials examining the effect
of exenatide extended-release for injectable suspension on daily blood glucose
variability compared with basal insulin (#997-P, Saturday, 14 June, 11:30 AM
PDT) iii  
 
·     A sub-group analysis from the SAVOR trial examining the effect of
saxagliptin on renal outcomes (#544-P, Saturday, 14 June, 11:30 AM PDT) iv  
 
·     An analysis from two double-blind, placebo-controlled trials evaluating
the effects of dapagliflozin on systolic blood pressure (#1033-P, Sunday, 15
June, 12:00 PM PDT) v  
 
·     A sub-group analysis from the SAVOR trial examining the effect of
saxagliptin in elderly patients from the study population (#1057-P, Sunday, 15
June, 12:00 PM PDT) vi  
 
·     An open-ended extension to the DURATION-1 trial examining the efficacy
and tolerability of exenatide once-weekly over six years (#964-P, Saturday, 14
June, 11:30 AM PDT) vii  
 
·     An analysis from five placebo-controlled trials examining the effects of
saxagliptin on β-cell function in patients with latent autoimmune diabetes
(#152-OR, Sunday, 15 June, 8:45 AM PDT) viii  
 
The complete list of AstraZeneca data presentations can be accessed on the ADA
website here. 
 
CONTACTS 
 
Media Enquiries 
 
Esra Erkal-Paler                          +44 20 7604 8030 (UK/Global) 
 
Vanessa Rhodes                         +44 20 7604 8037 (UK/Global) 
 
Ayesha Bharmal                          +44 20 7604 8034 (UK/Global) 
 
Jacob Lund                                  +46 8 553 260 20 (Sweden) 
 
Michele Meixell                            + 1 302 885 6351 (US) 
 
Investor Enquiries 
 
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654364 
 
Colleen Proctor                           + 1 302 886 1842     mob:  +1 302
357 4882 
 
Anthony Brown                            +44 20 7604 8067    mob: +44 7585
404943 
 
Jens Lindberg                             +44 20 7604 8414    mob: +44 7557
319729 
 
 i  Rosenstock, J., et al. "Dual Add-On Therapy in Poorly Controlled Type 2
Diabetes on Metformin: Randomized, Double-Blind Trial of
Saxagliptin+Dapagliflozin vs Saxagliptin and Dapagliflozin Alone." American
Diabetes Association Scientific Sessions 2014. Abstract #127-LB. 
 
 ii  Mansfield, T., et al. "Dapagliflozin is Safe and Well-tolerated in Older
patients with T2DM." American Diabetes Association Scientific Sessions 2014.
Abstract #269-OR. 
 
 iii  Vora, J., et al. "Daily Blood Glucose Variability With Exenatide
Once-Weekly Vs Basal Insulin in 3 RCTs." American Diabetes Association
Scientific Sessions 2014. Abstract #997-P. 
 
 iv  Mosenzon, O., et al. "Effect of Saxagliptin on Renal Outcomes." American
Diabetes Association Scientific Sessions 2014. Abstract #544-P. 
 
 v  Weber, M., et al. "Dapagliflozin Lowered Ambulatory Blood Pressure in
Patients With T2DM and Hypertension Inadequately Controlled by a
Renin-Angiotensin System Blocker With or Without Another Agent." American
Diabetes Association Scientific Sessions 2014. Abstract #1033-P. 
 
 vi  Leiter, L., et al. "Efficacy and Safety of Saxagliptin in Older
Participants in the SAVOR-TIMI 53 Trial." American Diabetes Association
Scientific Sessions 2014. Abstract #1057-P. 
 
 vii  Henry, R., et al. "An open-ended extension to the DURATION-1 trial
examining the efficacy and tolerability of exenatide once-weekly over six
years." American Diabetes Association Scientific Sessions 2014. Abstract
#964-P. 
 
 viii  Pozzilli P., et al. "Saxagliptin Increases β-Cell Function and Improves
HOMA Index in Patients with Latent Autoimmune Diabetes in Adults." American
Diabetes Association Scientific Sessions 2014. Abstract #152-OR. 
 
11 June 2014 
 
-ENDS- 
 
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